Shaohua Li1,2, Jie Mei1,2, Qiaoxuan Wang2,3, Zhixing Guo2,4, Lianghe Lu1,2, Yihong Ling2,5, Li Xu1,2, Minshan Chen1,2, Lie Zheng2,6, Wenping Lin1,2, Jingwen Zou1,2, Yuhua Wen1,2, Wei Wei7,8, Rongping Guo9,10. 1. Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. 2. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China. 3. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. 4. Department of Ultrasound, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. 5. Department of Pathology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. 6. Department of Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. 7. Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. weiwei@sysucc.org.cn. 8. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China. weiwei@sysucc.org.cn. 9. Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn. 10. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn.
Abstract
BACKGROUND: Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients. OBJECTIVE: This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI. METHODS: In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety. RESULTS:Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events. CONCLUSIONS: Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI. TRIAL REGISTRATION: Trial number: NCT03192618.
RCT Entities:
BACKGROUND: Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients. OBJECTIVE: This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI. METHODS: In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety. RESULTS: Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events. CONCLUSIONS: Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI. TRIAL REGISTRATION: Trial number: NCT03192618.
Authors: Alvina Jada Fok; Wong Hoi She; Ka Wing Ma; Simon H Y Tsang; Wing Chiu Dai; Albert C Y Chan; Chung Mau Lo; Tan To Cheung Journal: Langenbecks Arch Surg Date: 2021-08-18 Impact factor: 2.895